NOTION: iN-home Sampling Of cyTokines in ImmunOtherapy patieNts

NCT ID: NCT04960059

Last Updated: 2023-04-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-02-14

Study Completion Date

2024-12-01

Brief Summary

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This study will explore the ability of patients on first line combination immunotherapy to sample cytokines at home. The data from this study will be used to evaluate the feasibility of in-home testing and the ability to analyse patients cytokine profiles retrospectively to help feed the development of further studies.

Detailed Description

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Patients will be informed of the study and given a minimum of 24 hours to consider. Once consented patients will enter the study where they will take cytokine samples at home over a 12 week period.

Conditions

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Cancer Metastatic Melanoma Renal Cell Carcinoma Non-small Cell Lung Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Interventions

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No intervention

This is an observational study

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Voluntary informed consent.
* Aged at least 18 years.
* Diagnosis of locally advanced or metastatic RCC, Melanoma or NSCLC
* In the opinion of the investigator deemed suitable to receive first-line combination immunotherapy (RCC and MM) or combination immunotherapy and chemotherapy (NSCLC).
* Willingness to comply with scheduled trial procedures.
* Capable of performing own dry blood sampling procedure, or a carer who is willing and able to perform them.

Exclusion Criteria

* Previous immunotherapy (including any CPI either as single agent on in combination, or high dose interleukin-2).
* Judgement by the investigator that the individual should not participate if they are unlikely to comply with study procedures and requirements.
* Patients receiving long term oral anticoagulation deemed by the clinician to be at risk from daily finger pricking.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Manchester

OTHER

Sponsor Role collaborator

The Christie NHS Foundation Trust

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Donna Graham, MD

Role: PRINCIPAL_INVESTIGATOR

The Christie NHS Foundation Trust

Locations

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The Christie NHS Foundation Trust

Manchester, , United Kingdom

Site Status RECRUITING

Countries

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United Kingdom

Central Contacts

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Donna Graham, MD

Role: CONTACT

07881842794

Hannah Frost

Role: CONTACT

07881842794

Facility Contacts

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Leanna Goodwin

Role: primary

07881842794

Donna Graham

Role: backup

Other Identifiers

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CFTSp181

Identifier Type: -

Identifier Source: org_study_id

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